Gut Microbiome in People Living With HIV and HBV

Kangbuk Samsung Hospital

Status: Not yet enrolling

Conditions: Human Immunodeficiency Virus; Gut Microbiome; Chronic Hepatitis b

Study type: Observational

Funder types: Other

Identifiers

NCT06130137

HIVHBVgutmicrobiome

Details and patient eligibility

About

Building a Microbiome Data Platform and Conducting Clinical Evidence Research in Individuals Infected with the Human Immunodeficiency Virus (HIV) and Hepatitis B virus.

Full description

Chronic HIV infection, which often results in metabolic disorders, leads to shifts in the gut microbiota, contributing to immune activation and chronic inflammation. This study seeks to compare the gut microbiota in individuals with chronic HIV infection and chronic hepatitis B patients. The objective is to identify specific gut bacterial strains and metabolic pathways linked to the metabolic disorders commonly observed in HIV patients.

Enrollment: 200 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. HIV patients

   • Inidividuals over 19 years old
   • HIV patients on antiretroviral therapy (ART)

2. HBV patients

   • Individuals over 19 years old
   • Chronic hepatitis B patients with either chronic hepatitis, liver cirrhosis or hepatocellular carcinoma

Exclusion criteria

1. Patients with indeterminate colitis
2. Individuals who have used antibiotics or steroids within 24 hours of the microbiome sample collection (excluding antiviral treatments for hepatitis B and HIV)
3. Individuals who have used vaginal or external medications, including antifungal agents, within 24 hours of microbiome sample collection
4. Those with acute illnesses, with or without fever, of moderate or severe severity; however, sampling may be postponed until the subject recovers.
5. Individuals with gastrointestinal disorders that may impact microbiome analysis and are currently medically uncontrolled or under treatment for the respective condition
6. Individuals with a positive result in a urine pregnancy test, pregnant, or breastfeeding at the time of microbiome sample collection
7. Individuals for whom medical opinions suspect that they may have an impact on the sample collection at the time of microbiome collection.

Trial design

200 participants in 2 patient groups

HIV

Description:

Patients with HIV infection

HBV

Description:

Patients with HBV infection